Neck PainNCT05074641
Comparison Of Direct Myofascial Release And Bowen's Technique For Non-Specific Neck Pain
A study testing Direct myofascial release treatment and Bowen therapy in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
Neck pain is described as pain in the neck region that may or may not radiate to both the upper limbs and that will last for at least one day. Non-specific neck pain is the common cause of neck symptoms that is mainly due to mechanical causes, postural problem, depression, anxiety or occupational activities. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Direct myofascial release treatment and Bowen therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Feb 2021to 20 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic non-specific neck pain ≥ 3 months without symptoms radiating to the upper limbs
- Presence of a maximum of 1-2 active Myofascial Trigger Points
- Pain of more than 3 on a NPRS
- For the diagnosis of a Trigger Point, compliance with the following criteria:
- (1) A hypersensitive spot in a palpable taut band,
- (2) Palpable or visible local twitch on pincer palpation
- (3) Reproduction of referred pain elicited by palpation of the sensitive spot.
Who cannot join
- Diagnosed with cervical radiculopathy or myelopathy
- Neck Pain due to trauma, fractures, or whiplash; neoplasia, severe osteoporosis, infectious, or inflammatory processes;
- Patients with pacemakers, congenital anomalies, previous neck surgery
- Patients diagnosed with fibromyalgia syndrome according to the American College of Rheumatology criteria
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan Railway General Hospital
Rawalpindi, Punjab Province, 46000
About this study
Neck pain is described as pain in the neck region that may or may not radiate to both the upper limbs and that will last for at least one day. Non-specific neck pain is the common cause of neck symptoms that is mainly due to mechanical causes, postural problem, depression, anxiety or occupational activities. Poor posture causes abnormal muscle loading and muscle injury
Read the detailed description
Neck pain is described as pain in the neck region that may or may not radiate to both the upper limbs and that will last for at least one day.Poor posture causes abnormal muscle loading and muscle injury.It becomes a constant source of neck pain and instability. It reduces range of motion and weakens the shoulder and neck muscles. According to a population based survey the prevalence of lifetime neck pain ranges from 67% to 87%.
Trigger points cause myofascial pain syndrome which is among the leading cause of non-specific neck pain. Myofascial release technique (MRT) is often used to treat non-specific neck pain.Another therapy that focuses on myofascial work is Bowen therapy that follows a dynamic approach to release fascia and muscles. The technique involves very gentle cross fiber movements that are applied on fascia, muscles, tendons and viscera to induce the effect. The technique is applied at specific body regions following specific sequences with regular rest intervals that cause fascial stretching. The technique consists of slightly picking up muscles and then rolling the muscles to direct them toward a specific region of body. The rest periods help the body to integrate and absorb the effects of therapy. The sensory impulses caused by the Bowen therapy interact with nervous system and realign and correct the disturbed mechanisms.
- Conditions
- Neck Pain
- Being tested
- Direct myofascial release treatment, Bowen therapy
- Keywords
- Pain, Range of motion, Myofascial release, Bowen therapy, Anxiety
- Medical subject headings
- Neck Pain, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct myofascial release treatmentOther
Myofascial Release will be applied with Forearm and/or ulnar border of the palm. Deep Pressure will be applied and glided medially towards the base of the neck and/ or towards the upper scapular region
Bowen therapyOther
Thumb of the therapist will be placed on the top of the targeted muscle. The skin will be carried away gently from the spine without disturbing the muscle. The thumb was then hooked into the lateral aspect of the muscle to form a pressure on the muscle. Then the thumb will be flattened in the medial direction, when this happened the muscle would plop or respond in some way.
| Study group | Role | What they receive |
|---|---|---|
| Direct myofascial release treatment | Experimental | Myofascial Release will be applied with Forearm and/or ulnar border of the palm. Deep Pressure will be applied and glided medially towards the base of the neck and/ or towards the upper scapular region Receives: Other: Direct myofascial release treatment |
| Bowen therapy | Active comparator | Thumb of the therapist will be placed on the top of the targeted muscle. The skin will be carried away gently from the spine without disturbing the muscle. The thumb was then hooked into the lateral aspect of the muscle to form a pressure on the muscle. Then the thumb will be flattened in the medial direction, when this happened the muscle would plop or respond in some way. Receives: Other: Bowen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale
The Numeric pain rating scale is an 11-point numeric scale, it is the segmented numeric version of the visual analog scale. Subjects will be asked to mark/select a whole number for 0-10 that best describes their perceived pain intensity of the last 24 hours. zero indicates no pain and 10 is worst possible pain. assessment to be done at base line and after 2 weeks
Measured: for two weeks
Goniometer for Cervical Range of Motion
The active cervical range of motion (CROM) will be measured in sitting posture by using a universal goniometer, which consists of two arms; one that is stationary and one that is moveable. assessment to be done at base line and after 2 weeks
Measured: for two weeks
Neck Disability Index
it is a 10-item self-report questionnaire that measures the patient's disability related to his/her neck pain. It is the most commonly used questionnaire for neck disability; its reliability and validity has been demonstrated in many literatures and languages.its minimum score is zero no disability and 50 is maximum disability. Assessment to be done at base line and after 2 weeks
Measured: for two weeks
Depression Anxiety Stress Scale (DASS)
DASS is a reliable and validated tool commonly administered to measure the level of stress, depression and anxiety of the respondent. It is 42-item questionnaire that focuses on low mood, motivation, self-esteem, physiological arousal, perceived panic, fear, tension and irritability. Respondent answer each question by indicating the extent on a 4-point scale. In this study Urdu version of DASS is used which has concurrent validity of .87 for normal subjects and .84 for clinical population and .89 reliability. its minimum value is zero which is normal and maximum is 34 plus which is stress. Assessment to be done at base line and after 2 weeks
Measured: for two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start15 Feb 2021
- Primary completion20 Jan 2022
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Khalid, MSOMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074641
- Sponsor's protocol ID
- REC-00942 Shahzana khalid
- Status last verified
- Feb 2022
- First submitted
- 29 Sep 2021
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Direct Myofascial Release And Bowen's Technique For Non-Specific Neck Pain
- ClinicalTrials.gov ID
- NCT05074641
- Acronym / sponsor ID
- REC-00942 Shahzana khalid
- Conditions
- Neck Pain
- Keywords
- Pain, Range of motion, Myofascial release, Bowen therapy, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neck pain is described as pain in the neck region that may or may not radiate to both the upper limbs and that will last for at least one day. Non-specific neck pain is the common cause of neck symptoms that is mainly due to mechanical causes, postural problem, depression, anxiety or occupational activities. Poor posture causes abnormal muscle loading and muscle injury
Detailed description
Neck pain is described as pain in the neck region that may or may not radiate to both the upper limbs and that will last for at least one day.Poor posture causes abnormal muscle loading and muscle injury.It becomes a constant source of neck pain and instability. It reduces range of motion and weakens the shoulder and neck muscles. According to a population based survey the prevalence of lifetime neck pain ranges from 67% to 87%.
Trigger points cause myofascial pain syndrome which is among the leading cause of non-specific neck pain. Myofascial release technique (MRT) is often used to treat non-specific neck pain.Another therapy that focuses on myofascial work is Bowen therapy that follows a dynamic approach to release fascia and muscles. The technique involves very gentle cross fiber movements that are applied on fascia, muscles, tendons and viscera to induce the effect. The technique is applied at specific body regions following specific sequences with regular rest intervals that cause fascial stretching. The technique consists of slightly picking up muscles and then rolling the muscles to direct them toward a specific region of body. The rest periods help the body to integrate and absorb the effects of therapy. The sensory impulses caused by the Bowen therapy interact with nervous system and realign and correct the disturbed mechanisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct myofascial release treatment | Experimental | Other: Direct myofascial release treatmentMyofascial Release will be applied with Forearm and/or ulnar border of the palm. Deep Pressure will be applied and glided medially towards the base of the neck and/ or towards the upper scapular region |
| Bowen therapy | Active comparator | Other: Bowen therapyThumb of the therapist will be placed on the top of the targeted muscle. The skin will be carried away gently from the spine without disturbing the muscle. The thumb was then hooked into the lateral aspect of the muscle to form a pressure on the muscle. Then the thumb will be flattened in the medial direction, when this happened the muscle would plop or respond in some way. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Chronic non-specific neck pain ≥ 3 months without symptoms radiating to the upper limbs
- Presence of a maximum of 1-2 active Myofascial Trigger Points
- Pain of more than 3 on a NPRS
- For the diagnosis of a Trigger Point, compliance with the following criteria:
Key exclusion criteria (4 listed)
- Diagnosed with cervical radiculopathy or myelopathy
- Neck Pain due to trauma, fractures, or whiplash; neoplasia, severe osteoporosis, infectious, or inflammatory processes;
- Patients with pacemakers, congenital anomalies, previous neck surgery
- Patients diagnosed with fibromyalgia syndrome according to the American College of Rheumatology criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct myofascial release treatmentMyofascial Release will be applied with Forearm and/or ulnar border of the palm. Deep Pressure will be applied and glided medially towards the base of the neck and/ or towards the upper scapular region | Other | Direct myofascial release treatment |
| Bowen therapyThumb of the therapist will be placed on the top of the targeted muscle. The skin will be carried away gently from the spine without disturbing the muscle. The thumb was then hooked into the lateral aspect of the muscle to form a pressure on the muscle. Then the thumb will be flattened in the medial direction, when this happened the muscle would plop or respond in some way. | Other | Bowen therapy |
Primary outcome
Numeric pain rating scale
Time frame: for two weeks
The Numeric pain rating scale is an 11-point numeric scale, it is the segmented numeric version of the visual analog scale. Subjects will be asked to mark/select a whole number for 0-10 that best describes their perceived pain intensity of the last 24 hours. zero indicates no pain and 10 is worst possible pain. assessment to be done at base line and after 2 weeks
Goniometer for Cervical Range of Motion
Time frame: for two weeks
The active cervical range of motion (CROM) will be measured in sitting posture by using a universal goniometer, which consists of two arms; one that is stationary and one that is moveable. assessment to be done at base line and after 2 weeks
Neck Disability Index
Time frame: for two weeks
it is a 10-item self-report questionnaire that measures the patient's disability related to his/her neck pain. It is the most commonly used questionnaire for neck disability; its reliability and validity has been demonstrated in many literatures and languages.its minimum score is zero no disability and 50 is maximum disability. Assessment to be done at base line and after 2 weeks
Depression Anxiety Stress Scale (DASS)
Time frame: for two weeks
DASS is a reliable and validated tool commonly administered to measure the level of stress, depression and anxiety of the respondent. It is 42-item questionnaire that focuses on low mood, motivation, self-esteem, physiological arousal, perceived panic, fear, tension and irritability. Respondent answer each question by indicating the extent on a 4-point scale. In this study Urdu version of DASS is used which has concurrent validity of .87 for normal subjects and .84 for clinical population and .89 reliability. its minimum value is zero which is normal and maximum is 34 plus which is stress. Assessment to be done at base line and after 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Khalid, MSOMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct myofascial release treatment and Bowen therapy in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain rating scale (time frame: for two weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.